AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question Hi
What is the significance of testing endotoxins in parentral preperation .the normal limit is found 0.25EU/ml ..will excess may cause problems...and in case of anticoagulants the limit is 5.65 EU/ml ..and in medical devices limit is more ...why it is so...
Sreejith
Answer The presence of endotoxins can cause a cascade of body reactions/degradations leading to death (documented as being within 45 minutes of injection). The pharmacopoeal limits for injectables (0.25EU/mL) are set at a level that is below that causing body reaction.
other products have different limits based on the reality of the product. Most endotoxins are bacterial degradation products, but some chemicals (such as anti-coagulants) have there own inherent endotoxin impact - hence the different limits.
